Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment
Recruiting
Phase 1
Interventional Study
Advanced Malignancies and Hepatic Impairment
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
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About This Trial
The primary purpose of this study is to evaluate the impact of hepatic function on the pharmacokinetic (PK) profile of pelabresib in participants with advanced malignancies who have either hepatic impairment (HI) or normal liver function. To reduce participant burden and maximize benefit, the PK of pelabresib will be assessed at steady-state rather than after a single dose, avoiding treatment-free…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Is at least 18 and not older than 75 years of age at the time of signing the informed consent.
* Group 1 only: There is a matching participant in Group 2 and an enrollment slot is available for the Group 1 participant.
* Has a confirmed documented diagnosis of an advanced …
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